This Day On The Street
Continue to site right-arrow
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Vivus and Arena: A Tale of Dueling FDA Panel Minutes

Stocks in this article: ARNA VVUS

BOSTON ( TheStreet) -- The U.S. Food and Drug Administration has published the official minutes summarizing the discussion and outcomes of two advisory panels that reviewed the respective weight-loss drugs from Vivus (VVUS) and Arena Pharmaceuticals (ARNA).

Both panels voted to recommend approval but tell me which sounds more positive:

Here is how the 20-2 vote in favor of Vivus' Qnexa is summarized in the panel minutes:

"The committee members who voted 'YES' in question #5 noted that obesity is a disease for which there are inadequate treatment methods and that phentermine/topiramate (Qnexa) was shown to be effective in treating obesity with minimal adverse effects. However, they supported the requirement for a post-approval long-term cardiovascular (CV) safety trial which should be conducted expeditiously. It was noted that the sponsor should be held accountable for conducting and completing this CV trial. Additionally, these committee members agreed that the phentermine/topiramate REMS should capture additional data on long-term adverse events such as heart rate, psychological, cognitive functions, and birth defects. Several members highlighted the need to require treating physicians to be certified prior to treating patients with this agent and that the same requirement should be instituted for dispensing pharmacies. Lastly, the FDA was also urged to require the sponsor to continue to re-analyze any available data regarding reproductive outcomes such as birth defects."

And here's how the Arena panel's lorcaserin vote -- 18-4 (with one abstention) recommending approval -- is described:

"Many panel members indicated that it was a very difficult vote and they reluctantly voted 'Yes' that the benefits outweigh the risk for treatment of obesity patients since the magnitude of weight loss was moderate. Several panel members indicated that valvulopathy should be included in the Risk Evaluation and Mitigation Strategies (REMS) requirements and as part of the warning in the labeling and major adverse cardiovascular events (MACE) should be addressed as part of the phase 4 postmarketing cardiovascular trials requirements. Additional studies should be conducted to explore the issue of prolactin, tumor development, psychiatric effects and possible drug/drug interaction since this drug will probably be used in combination with other drugs. Echocardiogram should be required at the initiation of therapy and possibly at yearly physical check up."

Vivus' vote summary reads more positive than Arena's vote summary. No doubt about that, right?

Neither Qnexa nor lorcaserin comes across as pristine or perfect in their respective panel minutes. Qnexa's approval is expected to include significant warnings and a risk-management plan to deal with the potential risk of birth defects. The panel minutes reflect this:

"There was a general consensus from the committee that the data indicate an increase in the risk for oral clefs. However, it was difficult for the committee to discern whether the level of risk from the proposed dose of Qnexa (phentermine/topiramate) for obesity treatment would be comparable to that observed in the use of topiramate as a single-agent for other indications at higher doses. The committee noted that obesity in and of itself poses risks to the fetus. The committee suggested that additional methods for detecting birth defects may need to be implemented to further study the risk of oral clefs and other birth defects."

Vivus will be required to conduct a post-approval Qnexa heart-safety study because, "The committee agreed that there is not enough data at this time to adequately assess the cardiovascular (CV) risk for phentermine/topiramate," according to the minutes.

Arena's lorcaserin is also under a similar heart-safety cloud:

"The committee agreed that there is not sufficient data at this time to rule out a meaningful increase of risk of valvular heart disease. There is a concern that the upper bound to rule out an increase is around 1.5 and some of the analyses indicated that it’s higher than 1.5 and we would need further data to access this issue. The committee noted the need to conduct large studies to rule out valvular heart disease and assessment of other cardiac functions, such as cardiac remodeling, as part of the post-marketing requirement. There is a concern that in the real world when lorcaserin is taken in combination with other agents and the possibility of drug-drug interactions arises that this could lead to an increase in the risk of valvular heart disease. Therefore, the potential for drug-drug interactions; should be studied further. Several panel members indicated that an echocardiogram has do be done at the initiation of therapy and possibly during yearly physical check while the patient is on therapy. Some panel members were concerned that patients who lose the most weight will probably be taking the agent the longest and will be exposed to the agent longer leading to a possible increase in risk for valvular heart disease, which will need to be studied further."

And this:

"There was a general consensus from the committee that a cardiovascular outcome trial should be conducted but as part of the post approval requirements.

We only have to wait two more days until FDA issues its approval decision on Arena's lorcaserin. Vivus's turn with Qnexa comes on July 17.

--Written by Adam Feuerstein in Boston.

>To contact the writer of this article, click here: Adam Feuerstein.

>To follow the writer on Twitter, go to

>To submit a news tip, send an email to:

Follow TheStreet on Twitter and become a fan on Facebook.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 17,778.15 +421.28 2.43%
S&P 500 2,061.23 +48.34 2.40%
NASDAQ 4,748.3960 +104.0840 2.24%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs